New and Published Books
1-10 of 122 results in Drugs and the Pharmaceutical Sciences
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical...
Published October 29th 2014 by CRC Press
Solid Oral Dosage Forms, Second Edition
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory...
Published October 24th 2013 by CRC Press
Analytical Methods and Pharmacology, Third Edition
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition covers all aspects of chiral drugs from academic, governmental, industrial, and clinical perspectives, reflecting the many advances in techniques and methodology. Topics include: The use of enzymes in the synthesis and...
Published April 23rd 2012 by CRC Press
Compaction of powder constituents—both active ingredient and excipients—is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides...
Published August 22nd 2011 by CRC Press
Predicting Drug Degradation, Second Edition
The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The...
Published July 27th 2011 by CRC Press
The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that...
Published February 2nd 2011 by CRC Press
Formulation, Packaging, Manufacturing and Quality
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions,...
Published August 20th 2010 by CRC Press
The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing...
Published July 23rd 2010 by CRC Press
Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this...
Published June 15th 2010 by CRC Press
Prediction and Assessment, Second Edition
Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR...
Published March 25th 2010 by CRC Press
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, Second Edition
To Be Published December 14th 2015